FDA Panel Recommends Boosters For High Risk Or 65+ But Not For Younger

Image of a vaccine shot

An advisory committee to the FDA has recommended authorizing booster shots of the Pfizer-BioNTech coronavirus vaccine for those 65  or older or those at risk of severe cases of COVID-19. But the committee declined to approve boosters for the general population citing lack of compelling evidence. Continue reading “FDA Panel Recommends Boosters For High Risk Or 65+ But Not For Younger”

Gay Twitter Responds To FDA Warning On Poppers

(image via FDA)

The Food and Drug Administration recently issued warnings about the use of alkl nitrate inhalants (aka poppers) noting there’s been an increase of hospitalizations and even death associated with their use.

“These products are marketed as nail polish removers but are being ingested or inhaled for recreational use,” the statement reads.

“’Poppers’ are sold online or at adult novelty stores and packaged in small bottles, ranging from 10 to 40 mL. They appear similar to energy shots, with brand names including Jungle Juice, Extreme Formula, HardWare, Quick Silver and Super RUSH.”

How or why the FDA is suddenly aware of poppers that the gay community has used since the 1960s is a question many folks in the Twtterverse had, in addition to having quite the laugh about the warning itself.

FDA Approves Moderna Vaccine For COVID-19

(photo: Daniel Schludi/Unsplash)

The FDA has approved the coronavirus vaccine from Moderna for emergency use.

From CNBC:

The vaccine — the second approved for use in the U.S. behind Pfizer and BioNTech’s — bolsters the U.S. supply of doses. The potentially life-saving shots are desperately needed to fend off the pandemic that has taken more than 300,000 American lives and overwhelmed hospitals.

The FDA’s emergency use authorization Friday approves the federal government’s plan to distribute roughly 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the nation next week.

“We likely will see shots in the arm by the very early part of next week, I would hope Monday or Tuesday,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on the “Today” show on Friday morning.

At this writing, there have been 17,459,296 cases of COVID-19 in the U.S. with 313,588 American deaths.

Trump’s Coronavirus Cavalcade: October 7, 2020

Donald Trump leaves the hospital to wave to followers (photo: public domain)

In this edition of Donald Trump’s Coronavirus Cavalcade:

• After little-to-no effort to assauge the coronavirus in the White House working environment other than testing (that clearly failed), staffers have been instructed to wear full PPE gear when closely interacting with Donald Trump reports the New York Times. Even so, there are conflicting accounts as to whether Trump is working from the White House residence or in the Oval Office.

• The FDA has issued guidance recommending that participants in late-stage coronavirus vaccine clinical trials be followed for at least two months after the final injection to ensure safety and boost public trust in any approved vaccine.

• Trump adviser Stephen Miller is the most recent high-level White House adviser to test positive for the coronavirus. Additionally, one of Trump’s military aides who carries the ‘nuclear football’ has tested positive as well.

• Speaking of the ‘nuclear football,’ due to the medications Trump has received to treat coronavirus (including dexamethasone, which can cause mood swings and “frank psychotic manifestations”), the Bulletin of Atomic Scientists has issued a statement saying “we should not entrust nuclear launch authority to someone who is not fully lucid.”

• After more than a dozen White House staffers have tested positive for coronavirus, Vice President Mike Pence’s team has finally agreed to allow plexiglass barriers between himself and Democratic vice-presidential candidate Kamala Harris at tonight’s veep debate in light of the rash of positive cases within the White House.

• Donald Trump announced that he ordered Republicans to end negotiations for further coronavirus stimulus for Americans because some of the money would go to ‘Democrat’ states. Pssst, most of those states send the largest portion of tax dollars to the federal government. Oh, and blue state folks are Americans, too. 

FDA Withdraws Emergency Use Authorization Of Hydroxychloroquine For COVID-19

Pfizer has launched a large study to test its experimental oral drug to treat COVID-19

The FDA has pulled the emergency authorizations for using hydroxychloroquine for treating COVID-19 due to concerns about effectiveness and safety.

Donald Trump has spent the past couple of months heralding the drug as a miracle treatment for the novel coronavirus.

Via Politico:

The Food and Drug Administration on Monday withdrew emergency use authorizations for two coronavirus treatments promoted by President Donald Trump despite concerns about their safety and effectiveness.

The agency revoked the authorizations for hydroxychloroquine and chloroquine after a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority.

After reviewing new information from large clinical trials the agency now believes that the suggested dosing regimens “are unlikely to produce an antiviral effect,” FDA chief scientist Denise Hinton said in a letter announcing the decision.

Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence.

More recent randomized controlled trials have found the drugs do not benefit coronavirus patients, and doctors have reported that hydroxychloroquine can cause heart problems.

FDA To Authorize Emergency Use Of New Drug After ‘Optimistic’ Signs

The New York Times reports the F.D.A. is expected to authorize as early as Wednesday Gilead Sciences’ experimental anti-viral drug remdesivir for emergency use in treating patients with Covid-19.

Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, told reporters a trial study overseen by the National Institutes of Health showed clear signs the drug could make a difference in speeding up the recovery of some patients.

Dr. Fauci said the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third. “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Dr. Fauci said. “This is very optimistic.”

In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Dr. Fauci’s institute, known as NIAID. “We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.”

Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of Covid-19,” according to Gilead.

Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.

FDA Approves ‘Quick Result’ Coronavirus Test

The Washington Post reports the FDA has approved a new “rapid result” coronavirus test that can deliver results in 45 minutes.

The FDA granted “emergency use authorization” to Cepheid, a California company that makes a rapid molecular test for the coronavirus. Getting results in 45 minutes would be far quicker than the current situation in which tests typically are sent to central reference labs that can take days to deliver results.

The FDA authorization covers “patient care settings,” including doctors’ offices, but initially will be used primarily by hospitals and emergency departments, the company said.

The specimen can be collected either by a nasal swab or by a saline wash using a small catheter. Neither is particularly comfortable, but the advantage of the wash is that it doesn’t require swabs, which are in short supply.

Legal Age For Smoking Officially Raised To 21

(image via Luka Malic/Unsplash)

The Food and Drug Administration (FDA) has officially raised the legal age to buy tobacco products in the United States from 18 to 21, reports The Hill.

The move applies to all tobacco products, e-cigarettes and vaping cartridges, and comes after President Trump last week signed a $1.4 trillion spending package that included a measure raising the tobacco-buying age.

Initially, it was unclear when the age change would take effect. The FDA had six months to amend their policies after Trump signed the bill into law and then 90 days to put the change in place.

However, the FDA said in a message posted on its website that the change is now in effect.